This was a randomized, double-blinded, placebo-controlled, multiple-dose study in subjects with stable heart failure (HF) with reduced ejection fraction (HFrEF).
This was a randomized, double-blinded, placebo-controlled, multiple-dose study in subjects with stable heart failure (HF) with reduced ejection fraction (HFrEF). After completing the Screening period, a total of 71 subjects were randomized, in a 1:1:1 ratio, to receive either placebo, 4 mg elamipretide, or 40 mg elamipretide once daily for 28 consecutive days. Each treatment group went through 3 distinct periods: Screening, Treatment, and Follow up.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
71
Subcutaneous injection of 4 mg elamipretide administered once daily for 28 consecutive days
Subcutaneous injection of 40 mg elamipretide administered once daily for 28 consecutive days
Subcutaneous injection of placebo administered once daily for 28 consecutive days
A.O. Papa Giovanni XXIII Cardiologia 1, Torre 5
Bergamo, Italy
A.O. Spedali Civili di Brescia Cardiologia
Brescia, Italy
Change in Left Ventricular End Systolic Volume (ml)
Change in left ventricular end systolic volume as measured by ml from baseline (last assessment prior to start of study) to Week 4 (end of treatment visit) as assessed by MRI.
Time frame: Baseline to Week 4
Change in Left Ventricular Ejection Fraction (% of Blood Volume)
Change in Left Ventricular Ejection Fraction as measured by percentage of blood volume from baseline (last assessment prior to start of study) to Week 4 (end of treatment visit) as assessed by MRI.
Time frame: Baseline to Week 4
Change in Left Ventricular End Diastolic Volume (ml) as Measured by MRI
Change from baseline in Left Ventricular End Diastolic Volume as measured by ml from baseline (last assessment prior to start of study) to Week 4 (end of treatment visit) as assessed by MRI.
Time frame: Baseline to Week 4
Change in Left Ventricular Stroke Volume (ml)
Change in Left Ventricular Stroke Volume as measured by ml from baseline (last assessment prior to start of study) to Week 4 (end of treatment visit) as assessed by MRI.
Time frame: Baseline to Week 4
Change in Left Ventricular Cardiac Output (L/Min)
Change in Left Ventricular Cardiac Output as measured by L/min from baseline (last assessment prior to start of study) to Week 4 (end of treatment visit) as assessed by MRI.
Time frame: Baseline to Week 4
Change in Left Ventricular Myocardial Mass (g)
Change in Left Ventricular Myocardial Mass as measured by grams from baseline (last assessment prior to start of study) to Week 4 (end of treatment visit) as assessed by MRI.
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Azienda Ospedaliera Brotzu Cardiologia
Cagliari, Italy
Centro Cardiologico Monzino U.O. Scompenso, Cardiologia Clinica e Cardiologia Riabilitativa
Milan, Italy
Ospedale Niguarda Ca' Granda SC Cardiologia 2
Milan, Italy
Cardiologia clinica, Unità dello Scompenso e Terapia intensive Reparto Carlo Magno, Faggi Policlinico di Monza
Monza, Italy
Dip. Cardiotoracovascolare: Cardiologia Fondazione IRCCS Policlinico San Matteo Pad. Nuovo Ospedale "DEA" Degenza: PIANO +3 Ambulatori: P.T. e P+3
Pavia, Italy
Fondazione Toscana Gabriele Monasterio per la Ricerca Medica e di Sanità Pubblica
Pisa, Italy
Deventer Hospital, Department of Cardiology
Deventer, Netherlands
University Medical Centre Groningen
Groningen, Netherlands
...and 5 more locations
Time frame: Baseline to Week 4
Change in Right Ventricular End Systolic Volume (mL)
Change in Right Ventricular End Systolic Volume as measured by mL from baseline (last assessment prior to start of study) to Week 4 (end of treatment visit) as assessed by MRI.
Time frame: Baseline to Week 4
Change in Right Ventricular End Diastolic Volume (mL)
Change in Right Ventricular End Diastolic Volume as measured by ml from baseline (last assessment prior to start of study) to Week 4 (end of treatment visit) as assessed by MRI.
Time frame: Baseline to Week 4
Change in Right Ventricular Ejection Fraction (% Blood Volume)
Change in Right Ventricular Ejection Fraction as measured by percentage of blood volume from baseline (last assessment prior to start of study) to Week 4 (end of treatment visit) as assessed by MRI.
Time frame: Baseline to Week 4
Change in Early and Late Mitral Inflow Velocity Ratio
Change in Early and Late Mitral Inflow Velocity Ratio from baseline (last assessment prior to start of study) to Week 4 (end of treatment visit) as assessed by echocardiography.
Time frame: Baseline to Week 4
Change in Early Mitral Inflow Velocity and Mitral Annular Early Diastolic Velocity Ratio (E/e')
Change in Early Mitral Inflow Velocity and Mitral Annular Early Diastolic Velocity Ratio as measured by E/e' from baseline (last assessment prior to start of study) to Week 4 (end of treatment visit) as assessed by echocardiography.
Time frame: Baseline to Week 4
Change in Left Atrial Volume (mL)
Change in Left Atrial Volume as measured by ml from baseline (last assessment prior to start of study) to Week 4 (end of treatment visit) as assessed by echocardiography.
Time frame: Baseline to Week 4
Change in Left Ventricular Global Longitudinal Strain Assessment (%)
Change in Left Ventricular Global Longitudinal Strain Assessment as measured by ml from baseline (last assessment prior to start of study) to Week 4 (end of treatment visit) as assessed by echocardiography.
Time frame: Baseline to Week 4
Change in Left Ventricular End Diastolic Volume (mL) as Measured by Echocardiography
Change in Left Ventricular End Diastolic Volume as measured by ml from baseline (last assessment prior to start of study) to Week 4 (end of treatment visit) as assessed by echocardiography.
Time frame: Baseline to Week 4
Change in Left Ventricular End Systolic Volume (mL) as Measured by Echocardiography
Change in Left Ventricular End Systolic Volume as measured by ml from baseline (last assessment prior to start of study) to Week 4 (end of treatment visit) as assessed by echocardiography.
Time frame: Baseline to Week 4
Change in Biplane Ejection Fraction (mL)
Change in Biplane Ejection Fraction as measured by ml from baseline (last assessment prior to start of study) to Week 4 (end of treatment visit) as assessed by echocardiography.
Time frame: Baseline to Week 4
Left Ventricular Mass Assessment (g)
Change in Left Ventricular Mass Assessment as measured by grams from baseline (last assessment prior to start of study) to Week 4 (end of treatment visit) as assessed by echocardiography.
Time frame: Baseline to Week 4
Change in Tricuspid Regurgitation Severity Assessment (cm²)
Change in Tricuspid Regurgitation Severity Assessment as measured by cm from baseline (last assessment prior to start of study) to Week 4 (end of treatment visit) as assessed by echocardiography.
Time frame: Baseline to Week 4
Change in Right Ventricular Fractional Area (%)
Change Right Ventricular Fractional Area in as measured by percentage from baseline (last assessment prior to start of study) to Week 4 (end of treatment visit) as assessed by echocardiography.
Time frame: Baseline to Week 4
Change in Right Ventricular Systolic Pressure (mmHg)
Change in Change in Right Ventricular Systolic Pressure as measured by mmHg from baseline (last assessment prior to start of study) to Week 4 (end of treatment visit) as assessed by echocardiography.
Time frame: Baseline to Week 4
Change in Mitral Regurgitation Severity (cm²)
Change in Mitral Regurgitation Severity as measured by cm² from baseline (last assessment prior to start of study) to Week 4 (end of treatment visit) as assessed by echocardiography.
Time frame: Baseline to Week 4